NL-OMON39663已完成3 期
A phase III, multicenter, randomized, double-blind placebo-controlled study to assess the efficacy and safety of Tocilizumab in subjects with giant cell arteritis. - Roche GCA WA28119
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Able and willing to provide written informed consent and to comply with the study protocol
- •- Diagnosis of GCA
- •- New-onset or refractory active disease
排除标准
- •- Major surgery within 8 weeks prior to screening or planned major surgery within 12 months after randomization
- •- Transplanted organs (except corneal transplant performed more than 3 months prior to screening)
- •- Major ischemic event, unrelated to GCA, within 12 weeks of screening
- •- Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to Campath (alemtuzumab), anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20
- •- Treatment with IV gamma globulin or plasmapheresis within 6 months of baseline
- •- Previous treatment with alkylating agents, such as chlorambucil, or with total lymphoid irradiation
- •- Previous treatment with TCZ
- •- Immunization with a live/attenuated vaccine within <= 4 weeks prior to baseline
- •- Treatment with hydroxychloroquine, cyclosporine A, azathioprine, or MMF within 4 weeks of
- •- Treatment with etanercept within 2 weeks; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks; or anakinra within 1 week of baseline
- •- Previous treatment with tofacitinib
- •- Treatment with cyclophosphamide within 6 months of baseline
- •- Patients requiring systemic CS for other conditions other than GCA, which, in the opinion of the investigator, would interfere with adherence to the fixed CS taper regimen and/or to assessment of efficacy in response to the test article
- •- Chronic use of systemic CS for > 4 years or inability, in the opinion of the investigator, to withdraw CS treatment through protocol-defined taper regimen due to suspected or established adrenal insufficiency
- •- Receipt of > 100 mg daily intravenous methylprednisolone within 6 weeks of baseline
- •- Active TB requiring treatment within the previous 3 years
- •- Females of childbearing potential and females who are breastfeeding
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